Therapeutic effect of Flortec (Registered Trademark) in the treatment of acute gastroenteritis in children

Therapeutic effect of Flortec (Registered Trademark) in the treatment of acute gastroenteritis in children Introduction Acute gastroenteritis is one of the most frequent problems encountered in pediatric clinical practice with a significant epidemiological and economic weight. Only in Italy there are more than 2 million episodes of acute gastroenteritis in children aged <3 years. From the economic point of view the overall cost of an episode of acute gastroenteritis managed at home is approximately 110 Euro for the family inclusive of working days lost by parents, pediatric visits, purchase of medicines and other medical devices. Rehydration by administration of oral rehydration solution (ORS) is the key moment of the treatment of children with acute gastroenteritis. Unfortunately, the ORS is still widely under-used in industrialized countries because of the lack of efficacy on the symptoms of diarrhea. This implicates a large use of drugs and probiotics, prebiotics and symbiotics even if there are no clear evidence of clinical efficacy in the treatment of acute gastroenteritis in children. Aim To evaluate the efficacy and acceptability of a new symbiotic formulation called FLORTEC in the treatment of acute gastroenteritis in children. Methods Children aged between 3 and 36 months with acute gastroenteritis defined as increase in the number of bowel movements (> 3 / 24 h) and / or changes in stool consistency; Onset of symptoms <48 hours prior to enrollment. Evidence of mild to moderate dehydration. Exclusion criteria - Age <3 months > 3 years - Dystrophy (weight/lenght <5 centile) - Duration of diarrhea > 48 hours - food allergies/ intolerances - Assumption of substances that alter the intestinal microflora (probiotics, prebiotics and antibiotics) or have adsorption properties (diosmectite) or modify the intestinal secretion (racecadotril, loperamide) - Chronic bowel diseases (celiac disease, inflammatory bowel diseases, cystic fibrosis or other forms of primitive pancreatic insufficiency) - Primary or secondary gastrointestinal malformations (intestinal atresia, short bowel syndrome, etc.). - Primary or secondary immunodeficiencies - Systemic infections Intervention At the enrollment patients will be randomly allocated into one of the following groups: - Group 1: standard ORS (Na + 60 mmol / l, glucose 75-100mOsmol / l, osmolarity 225 - 260 mOsmol / l) + Flortec: symbiotic product on the market in the form of 6.0 g packets containing a powder consisting of Lactobacillus paracasei B21060 (2.5x109 CFU), fructo-oligosaccharides (700 mg), glutamine (500 mg) and arabinogalactan (500 mg): 1 packets 2 time/day for 5 days. - Group 2: standard ORS + placebo: a packet identical external appearance and containing the same quantity of powder in appearance and taste very similar to Flortec: 1 packet 2 time/day for 5 days. Patients will receive prescription for the self-purchase of medication. Enrolled patients will receive oral rehydration with ORS in the following ways: - Mild dehydration: 30-50 ml / kg of ORS in the first 4 hours from diagnosis - Moderate dehydration: 50-100 ml / kg of ORS in the first 4 hours from diagnosis Subsequently receive 10 ml of ORS per Kilogram of body weight to prevent dehydration until the end of symptoms. Outcome indicators Primary: Duration of diarrhea determined in hours from onset of symptoms until the last evacuation of loose stools, followed by 24 hours of regular bowel function (<3 of evacuations / day of formed stool). Secondary: - Rate of patients presenting diarrhea after 48 h of treatment. - Severity of diarrhea evaluated by the number of evacuations per day and the characteristics of the evacuations, according to the following points: 3, liquid, 2, semiliquid; 1, soft; 0, normal. - Incidence of protracted diarrhea: duration of symptoms> 7 days. - Adherence to treatment - Need for hospitalization - Episodes of intestinal infections in the 2 weeks after treatment. Data Collection Data were collected by record form. At the enrollment pediatrician must: verify the inclusion criteria, inform children’s parents/tutors about the goals and procedures of the trial, fill out the initial part of the data collection form, deliver the package to the parents/tutors corresponding to the randomization procedure and the data form, plan the next clinical control of the child. Power study 45 patients are required for each group in order to obtain a power equal to 95% of the study. Type 1 error = 0.05. This number considers a difference in the average duration of diarrhea of 24 hours between the groups (120 hours vs. 96 hours) including a standard deviation of 30 hours. The total number was increased to 100 by estimating a drop out of 10%.